Study on the Serum Metabolic Markers and Early Complications After Allo-HSCT： Cohort Study

NCT06386445 | Not Yet Recruiting

• 1 other identifier: XJTU1AF-CRF-2023-XK013
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to establish a cohort of 500 patients with hematological disease who undergoing allogeneic hematopoietic stem cell transplantation in the northwest region. All patients will be followed up at the outpatient clinic once a week after transplantation until 100 days after transplantation to observe the presence of acute graft versus host disease, acute kidney damage, and major cardiovascular adverse events. Serum samples from the day before pre-treatment, day after pre-treatment, 2 weeks，4 weeks，8 weeks and 12 weeks after transplantation will be detected by metabolomics sequencing.The primary objective is to explore the serum metabolic markers of acute graft versus host disease，acute kidney injury, and major adverse cardiac events within 100 days after transplantation，the secondary objective is to observe the high-risk factors for early complications.

Conditions

Stem Cell Transplant Complications; Acute Graft Versus Host Disease; Acute Kidney Injury; Major Adverse Cardiac Events

Outcome Measures

Primary Outcomes (1)

• acute graft versus host disease

  skin，liver and gastrointestinal acute graft versus host disease

  within 100 days after transplantation

Secondary Outcomes (2)

• acute kidney injury

  within 100 days after transplantation

• major adverse cardiac events

  within 100 days after transplantation

Study Arms (1)

XJTU Cohort of allo-HSCT

all the patients underwent allogeneic stem cell transplantation

Other: Serum metabolomics sequencing

Interventions

Serum metabolomics sequencing OTHER

Serum samples from the day before pre-treatment, day after pre-treatment, 2 weeks，4 weeks，8 weeks and 12 weeks after transplantation will be detected by metabolomics sequencing.

XJTU Cohort of allo-HSCT

Eligibility Criteria

• Age: 0 Years - 65 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with hematological disease underwent allogeneic stem cell transplantation

You may qualify if:

• Age ≤ 65 years old;
• Gender unlimited;
• Normal heart and kidney function before transplantation;
• Patients with indications for allogeneic hematopoietic stem cell transplantation.

You may not qualify if:

• CREA or BUN higher than the normal upper limit value before transplantation;
• Individuals with a history of arrhythmia, heart failure, or PCI stent implantation prior to transplantation;
• Patients with mental illness;
• Those who are unwilling to sign informed consent.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Acute Kidney Injury; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• pengcheng he, M.D.

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY DIRECTOR

Central Study Contacts

xiaonig wang, M.D.

CONTACT

02985323473; wangxn99@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 26, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share